Systems and methods for determining an end of life state for surgical devices

ABSTRACT

The present disclosure is directed to systems and methods for determining an end of life state for an electromechanical surgical system. The system includes an end effector configured to perform at least one function and a shaft assembly being arranged for selectively interconnecting the end effector and a hand-held surgical instrument. The hand-held surgical instrument includes an instrument housing defining a connecting portion for selectively connecting with the shaft assembly. The hand-held surgical instrument also includes a motor assembly, a sensor array configured to obtain an operational parameter of the hand-held surgical instrument, and a controller configured to control operation of the hand-held surgical instrument based on the operational parameter obtained by the sensor array.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of and priority to U.S. ProvisionalPatent Application No. 61/985,081, filed Apr. 28, 2014, the entiredisclosure of which is incorporated by reference herein.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical apparatus, devices and/orsystems for performing minimally invasive surgical procedures andmethods of use thereof. More specifically, the present disclosurerelates to systems and methods for determining an end of life state forelectromechanical, hand-held surgical apparatus, devices and/or systemsconfigured for use with removable disposable loading units and/or singleuse loading units for clamping, cutting and/or stapling tissue.

2. Background of Related Art

A number of surgical device manufacturers have developed product lineswith proprietary drive systems for operating and/or manipulatingelectromechanical surgical devices. Some electromechanical surgicaldevices include a handle assembly, which is reusable, and replaceableloading units and/or single use loading units or the like that areselectively connected to the handle assembly prior to use and thendisconnected from the handle assembly following use, in order to bedisposed of or in some instances sterilized for re-use.

Typically, electromechanical surgical devices have an end of life thatis predetermined during the engineering development phase and hard setwithin each device that is sold. Thus, all the devices have an identicallifespan regardless of factors which may reduce or prolong useful lifeof the device.

Accordingly, a need exists for determining an end of life state forelectromechanical surgical apparatus, devices and/or systems in order toreduce or prolong the useful life of the device.

SUMMARY

In embodiments of the present disclosure, an electromechanical surgicalsystem is provided. The system includes an end effector configured toperform at least one function and a shaft assembly being arranged forselectively interconnecting the end effector and a hand-held surgicalinstrument. The hand-held surgical instrument includes an instrumenthousing defining a connecting portion for selectively connecting withthe shaft assembly. The hand-held surgical instrument also includes amotor assembly, a sensor array configured to obtain an acoustic metricor electrical metric of the hand-held surgical instrument, and acontroller configured to control operation of the hand-held surgicalinstrument based on the acoustic metric or electrical metric obtained bythe sensor array.

In some aspects, the hand-held surgical instrument includes atransceiver configured to communicate with an external device. Theexternal device is a charging device, a local server, or an externalserver. The hand-held surgical instrument may communicate with thecharging device, the local server, or the external server via a cloud.

In some aspects, the sensor array includes at least one acoustic sensor,temperature sensor, voltage sensor, current sensor, or vibration sensor.

In another embodiment of the present disclosure, an end of life statedetermination method for a hand-held surgical instrument is provided.The method includes obtaining at least one acoustic or electrical metricof the hand-held surgical instrument. The method also includes comparingthe at least one acoustic or electrical metric to a threshold value anddisabling the hand-held surgical instrument when the at least oneacoustic or electrical metric is greater than the threshold value.

In some aspects, the method further includes presetting the thresholdvalue by a manufacturer. In other aspects, the method further includessetting the threshold value as a function of a measured characteristic.In yet other aspects, the method further includes adjusting thethreshold value as a function of continually aggregated field data. Thecontinually aggregated field data is at least one of device performance,geographical metrics, hospital condition metrics, clinician metrics,regional based performance metrics, geographic based performancemetrics, or time zone based performance metrics.

In yet another embodiment of the present disclosure, an end of lifestate prolonging method for a hand-held surgical instrument is provided.The method includes obtaining at least one operational parameter of thehand-held surgical instrument. The method also includes comparing the atleast one operational parameter to a predetermined threshold value anddetermining that a device parameter of the hand-held surgical instrumentcan be augmented when the at least one operational parameter is greaterthan the predetermined threshold value. When the device parameter can beaugmented, the method also includes augmenting the device parameter ofthe hand-held surgical instrument.

In some aspects, the hand-held surgical instrument is disabled if thedevice parameter of the hand-held surgical instrument cannot beaugmented.

In some aspects, the method further includes setting the threshold valueby a manufacturer. In other aspects, the method further includes settingthe threshold value as a function of a measured characteristic duringmanufacturing. In yet other aspects, the method further includes settingthe threshold value as a function of continually aggregated field data.The continually aggregated field data is at least one of deviceperformance, geographical metrics, hospital condition metrics, clinicianmetrics, regional based performance metrics, geographic basedperformance metrics, or time zone based performance metrics.

Further details and aspects of exemplary embodiments of the presentdisclosure are described in more detail below with reference to theappended figures.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure are described herein withreference to the accompanying drawings, wherein:

FIG. 1 is a perspective view of an electromechanical surgical systemthat may incorporate systems or methods in accordance with embodimentsof the present disclosure;

FIG. 2 is a system block diagram of an end of life state determinationsystem in accordance with embodiments of the present disclosure;

FIG. 3 is a system block diagram of the sensor array of FIG. 2;

FIG. 4 is a system block diagram of a communication network inaccordance with embodiments of the present disclosure;

FIG. 5 is a flow chart depicting an end of life state determinationmethod in accordance with embodiments of the present disclosure;

FIG. 6 is a flow chart depicting a method for prolonging the end of lifein accordance with embodiments of the present disclosure;

FIG. 7 is a chart depicting an augmentation event for prolonging the endof life of an instrument in accordance with an embodiment of the presentdisclosure;

FIG. 8A is a chart and FIG. 8B is a table used to set a threshold valuefor an instrument in accordance with an embodiment of the presentdisclosure; and

FIG. 9 is a chart depicting the collection of data to determine the endof life state of an instrument in accordance with an embodiment of thepresent disclosure.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed electromechanical surgicalsystem, apparatus and/or device are described in detail with referenceto the drawings, in which like reference numerals designate identical orcorresponding elements in each of the several views. As used herein theterm “distal” refers to that portion of the electromechanical surgicalsystem, apparatus and/or device, or component thereof, that are fartherfrom the user, while the term “proximal” refers to that portion of theelectromechanical surgical system, apparatus and/or device, or componentthereof, that are closer to the user.

This description may use the phrases “in an embodiment,” “inembodiments,” “in some embodiments,” or “in other embodiments,” whichmay each refer to one or more of the same or different embodiments inaccordance with the present disclosure. For the purposes of thisdescription, a phrase in the form “A or B” means “(A), (B), or (A andB)”. For the purposes of this description, a phrase in the form “atleast one of A, B, or C” means “(A), (B), (C), (A and B), (A and C), (Band C), or (A, B and C)”.

The term “clinician” refers to any medical professional (i.e., doctor,surgeon, nurse, or the like) performing a medical procedure involvingthe use of embodiments described herein. As shown in the drawings anddescribed throughout the following description, as is traditional whenreferring to relative positioning on a surgical instrument, the term“proximal” or “trailing” refers to the end of the apparatus which iscloser to the clinician and the term “distal” or “leading” refers to theend of the apparatus which is further away from the clinician.

The systems described herein may also utilize one or more controllers toreceive various information and transform the received information togenerate an output. The controller may include any type of computingdevice, computational circuit, or any type of processor or processingcircuit capable of executing a series of instructions that are stored ina memory. The controller may include multiple processors and/ormulticore central processing units (CPUs) and may include any type ofprocessor, such as a microprocessor, digital signal processor,microcontroller, or the like. The controller may also include a memoryto store data and/or algorithms to perform a series of instructions.

Any of the herein described methods, programs, algorithms or codes maybe converted to, or expressed in, a programming language or computerprogram. A “Programming Language” and “Computer Program” is any languageused to specify instructions to a computer, and includes (but is notlimited to) these languages and their derivatives: Assembler, Basic,Batch files, BCPL, C, C+, C++, Delphi, Fortran, Java, JavaScript,Machine code, operating system command languages, Pascal, Perl, PL1,scripting languages, Visual Basic, metalanguages which themselvesspecify programs, and all first, second, third, fourth, and fifthgeneration computer languages. Also included are database and other dataschemas, and any other meta-languages. For the purposes of thisdefinition, no distinction is made between languages which areinterpreted, compiled, or use both compiled and interpreted approaches.For the purposes of this definition, no distinction is made betweencompiled and source versions of a program. Thus, reference to a program,where the programming language could exist in more than one state (suchas source, compiled, object, or linked) is a reference to any and allsuch states. The definition also encompasses the actual instructions andthe intent of those instructions.

Any of the herein described methods, programs, algorithms or codes maybe contained on one or more machine-readable media or memory. The term“memory” may include a mechanism that provides (e.g., stores and/ortransmits) information in a form readable by a machine such a processor,computer, or a digital processing device. For example, a memory mayinclude a read only memory (ROM), random access memory (RAM), magneticdisk storage media, optical storage media, flash memory devices, or anyother volatile or non-volatile memory storage device. Code orinstructions contained thereon can be represented by carrier wavesignals, infrared signals, digital signals, and by other like signals.

In embodiments described herein, a powered surgical device collectsvarious forms of data from the device and compares the collected data toa threshold. Based on the comparison, specific actions can be taken withregard to the end of life state of the device. For instance, thecollected data may exhibit that the device has prematurely reached itsend of life state and prevent use of the device. In other instances, thedevice may make adjustments to prolong the end of life of the device.

The systems and methods described herein would permit the possibility ofextending the life ofr powered surgical devices. It will also allow anyunits that exhibit a premature end of life failure to be safely removedprior to use on a patient. The systems may also include wirelesscapability and can be connected to the cloud in order to transmitinformation for analysis in real time. Through electronic signatureanalysis the system may determine that a limited number of proceduresare remaining before an end of life state is reached. The systemperformance as well as any supply requirements may be transmitted to asurgical coordinator via an email, text message, or both. Data collectedfrom the field can be analyzed to determine if there are any prematurecomponent failures that may affect other units in the field, allowingmanufacturing to be proactive in addressing any possible field issues.

Referring initially to FIG. 1, an electromechanical, hand-held, poweredsurgical system, in accordance with embodiments of the presentdisclosure is shown and generally designated 10. Electromechanicalsurgical system 10 includes a surgical apparatus or device in the formof an electromechanical, hand-held, powered surgical instrument 12 thatis configured for selective attachment thereto of a plurality ofdifferent end effectors 14, via a shaft or adapter assembly 16, that areeach configured for actuation and manipulation by the electromechanical,hand-held, powered surgical instrument 12. In particular, surgicalinstrument 12 is configured for selective connection with shaft assembly16, and, in turn, shaft assembly 16 is configured for selectiveconnection with any one of a plurality of different end effectors 14.

For a detailed description of the construction and operation ofexemplary electromechanical, hand-held, powered surgical instrument 12,reference may be made to International Application No.PCT/US2008/077249, filed Sep. 22, 2008 (Inter. Pub. No. WO 2009/039506)and U.S. patent application Ser. No. 12/622,827, filed on Nov. 20, 2009(U.S. Patent Application Publication No. 2011/0121049), the entirecontents of each of which are hereby incorporated herein by reference.

FIG. 2 is a system block diagram of an electromechanical, hand-held,powered surgical system, in accordance with embodiments of the presentdisclosure. As shown in FIG. 2, the powered surgical instrument 12includes a controller 18 having a central processing unit (CPU) 20 and amemory 22. An input device 24 may include buttons, knobs, switches orthe like to control the powered surgical instrument 12. A transceiver 26transmits and receives data between the powered surgical instrument 12and an external source as will be described below with reference to FIG.4. The instrument 12 also has a motor assembly 27 that includes a motor28 and, in certain embodiments, a gearbox 30. The controller 28 andmotor assembly 27 control operation of the shaft assembly 16 and the endeffector 14. The powered surgical instrument 12 also includes a sensorarray 32 that measures operational parameters, e.g., acoustic basedmetrics or electrical based metrics, of the instrument 12. As shown inFIG. 3, sensor array 32 may include one or more acoustic sensors 34,temperature sensors 36, voltage sensors 38, current sensors 40, andvibration sensors 42. As will be described in more detail below, thecontroller 28 controls operation of the powered surgical instrument 12based on the measured operational parameter provided by the sensor array32. In some instances, the controller 28 may decide that the poweredsurgical instrument may or may not be used based on the measuredoperational parameter. In other instances, the controller 28 may adjustoperation of the individual components in the powered surgicalinstrument 12 during operation of the instrument 12 based on themeasured operational parameter.

Referring to FIG. 4, the powered surgical instrument 12 is able tocommunicate via transceiver 26 with a dock 44. Dock 44 may be a testfixture or a charging device. The instrument 12 may be directly coupledto the dock 44 by a wired connection or instrument 12 may be wirelesslycoupled to dock 44 using any known wireless communication method. Theinstrument 12 and the dock 44 may transmit or receive data from a cloud46, which is a network of remote servers hosted on the Internet and usedto store, manage, or process data in place of local servers or personalcomputers. A local server 48, e.g., a hospital server, or an externalserver 50, e.g., a manufacturer's server, may extract data regarding theinstrument 12 from the cloud 46 or transmit data to the instrument 12via the cloud 46.

Referring to FIGS. 1-4, the powered surgical instrument 12 is able todetermine, or collect information in order to determine when theinstrument 12 will reach the end of life state. In an embodiment of thepresent disclosure, the sensor array 32 is able to detect vibro-acousticresponses and natural harmonic frequencies of rotational or lineardriven electromechanical drive components within the system 10 based ontheir numerical physical attributes. Such numerical physical attributesinclude: (i) the number of balls, pins, or needles of any bearingsand/or their driven revolutions per minute (RPM); (ii) the number ofgear or worm teeth or the mesh frequency of any gears and/or theirdriven RPM; (iii) the number of radial pins on carriers, number ofplanets on planetary gear sets of any transmissions and/or their drivenRPM; (iv) the number of radial splines or features or universal jointsof any couplings and/or their driven RPM; (v) the unsupported beamharmonic frequency range of any linear drives and/or their driven RPM;(vi) the number of armature magnet poles or field slots (based onarchitecture) of any motors and/or their driven RPM; (vii) the number ofradial lobes or features of any cams and/or their driven RPM; (viii) thenumber of radial features on a cog pulley and/or their driven RPM; and(ix) the number of fan blades or impellers and/or their driven RPM. Theabove list is meant to merely serve as an example of components withinthe system 10 that emit a vibro-acoustic response and is not meant to bea complete list of all components within system 10 that emit avibro-acoustic response.

The sensor array 32 monitors the specific natural harmonic frequenciesof the electromechanical drive components to determine the acousticamplitude limits for a performance degradation and/or reliabilityconfidence threshold for each component. Such acoustic amplitude limitsfor each specific component within the system 10 can be measured orgauged or assimilated with any form or combination of acoustic orvibration sensors which can include, but are not limited to,accelerometers, electromagnetic inductors, piezoelectric generators,capacitance or electrostatic microphones. Although sensor array 32 hasbeen described as being in the instrument 12, the sensor array may bedisposed in the dock 44. During manufacturing, acoustic amplitude limitsare stored as threshold values within memory 22. In some embodiments,the threshold values may also be stored in dock 44. During operation ofthe instrument 12, controller 18 utilizes the stored threshold values toimplement any of the following tasks independently or in any combinationwithin the product or subassembly: shut down the device, determine/setspecific operational modes, adjust life or use estimations, generateerror codes and/or initiate service calls for each specific issue.Adjustment of the life of the product may be determined by algorithmsusing empirical testing data, analytic predictions etc. of any sensordata.

In other embodiments, the sensor array 32 monitors electricalproperties, e.g., voltage drop or current draw, of various electricalcomponents. The electrical properties are monitored during manufacturingand used to set threshold values that are stored in memory 22. Thecontroller 18 may then monitor the electrical properties of instrument12 and compare the electrical properties to the stored threshold valuesto implement any of the following tasks independently or in anycombination within the product or subassembly: shut down the device,determine/set specific operational modes, adjust life or useestimations, generate error codes and/or initiate service calls for eachspecific issue.

FIG. 5 depicts an end of life state determination method in accordancewith an embodiment of the present disclosure. As shown in FIG. 5, theinstrument 12 is activated in step s100. In step s102, one or moreoperational parameters, e.g., acoustic data or electrical data, iscollected and compared to a threshold in step s104. If the value of theone ore more operational parameters is less than or equal to thethreshold value, the process returns to steps s102 to collect moreoperational parameters. If the value of the one ore more operationalparameters is greater than the threshold value, the process proceeds tostep s106 where the controller 18 determines that the instrument 12 hasreached the end of life state. Controller 18 then disables theinstrument 12 in step s108.

FIG. 6 depicts a method for prolonging the end of life in accordancewith embodiments of the present disclosure. As shown in FIG. 6, theinstrument 12 is activated in step s200. In step s202, one ore moreoperational parameters, e.g., acoustic data or electrical data, iscollected and compared to a threshold in step s204. If the value of theone ore more operational parameters is less than or equal to thethreshold value, the process returns to step s202 to collect moreoperational parameters. If the value of the one ore more operationalparameters is greater than the threshold value, the process proceeds tostep s206 where the controller 18 determines whether a device parameteror parameters may be augmented to extend the end of life of theinstrument 12. For instance, as shown in FIG. 7, the instrument 12 maymonitor the performance of the motor 28, e.g., between 150 cycles and200 cycles, the performance of the motor drops below an acceptablelimit. To correct the performance of the motor 28, the voltage suppliedto the motor 28 may be increased or augmented to increase theperformance of the motor to an acceptable level.

If the controller 18 determines that the device parameter(s) can beaugmented, the process proceeds to steps s208 where the instrument 12triggers the augmentation effect. If the device parameter(s) cannot bealtered, the process proceeds to step s210 where the controller 18disables the device. The controller 18 may determine that the deviceparameter(s) cannot be altered based on a threshold level, capability ofa component to be altered, etc.

The threshold values used in steps s104 and s204 may be set, forexample, in one of three ways. In some embodiments, the same thresholdvalues may be set as a static or dynamic limit for all similar devices.In other embodiments, the static or dynamic limit may be set as afunction of a measured characteristic during manufacturing or initialcalibrations as will be discussed below with regard to FIGS. 8A and 8B.In yet other embodiments, the static or dynamic limit may be set asfunction of continually aggregated field data as shown in FIG. 9.

FIGS. 8A and 8B depict an example of the determining an end of lifestate for a motor that may be used in the instrument 12 duringmanufacturing or initial calibrations using typical data. As shown inFIG. 5A, an acoustic profile for five sample motors are taken initially.The acoustic profile of the five sample motors can be captured byacoustic or vibration sensors. FIG. 5A shows the decibel (dB) level ofthe five sample motors for each frequency domain between 20 and 20,000Hz. After the acquisition of the initial acoustic profile, the motorsare subjected to end of life testing to determine how long each samplecan perform as expected until failure. As shown in FIG. 5B, the fivesample motors reach the end of life state after varying number ofcycles. For example, sample “1” has been through 25 cycles, sample “2”has been through 500 cycles, sample “3” has been through 490 cycles,sample “4” has been through 501 cycles, and sample “5” has been through486 cycles. Thus, a conclusion can be drawn that a motor (sample 1) witha high dB level in a specific frequency band (see Note A in FIG. 8A) islikely to fail at a low number of uses. This information may be used tolimit use of the instrument in the field or the component may bescrapped altogether.

FIG. 9 depicts an example of aggregating field data to set a thresholdvalue. As shown in FIG. 9, acoustic data can be recorded by a device asit is used. This data can be monitored by the device for one or moretriggering events which can include the passing of a set hard limit, orthe occurrence of a sudden increase in a measured reading. (See Note Bin FIG. 9.) This information can be used to anticipate a failure andfacilitate a “safe failure” situation. In some embodiments, thistechnique can be applied in reverse to extend the lifespan of a device.For example, instead of simply limiting device life to 300 cycles thistechnique can leave the end of life open ended. If a device isperforming well it can decide independently that it does not need tolimit itself to 300 uses.

The performance of instrument 12 and/or its components is only one typeof data that may be aggregated to determine the threshold value of theinstrument 12. Other data that may be used include: (i) metrics based ongeographic or hospital conditions; (ii) user or clinician metrics; and(iii) regional, geographic, or time zone based performance metrics. Themetrics may be used to determine the end of life of the instrument 12 oradjust the operating parameters of the instrument 12. These metrics maybe analyzed by the instrument 12, the dock 44, local server 48, orexternal server 50.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, surgical instrument 100and/or cartridge assembly 410 need not apply staples but rather mayapply two part fasteners as is known in the art. Further, the length ofthe linear row of staples or fasteners may be modified to meet therequirements of a particular surgical procedure. Thus, the length of thelinear row of staples and/or fasteners within a staple cartridgeassembly may be varied accordingly. Therefore, the above descriptionshould not be construed as limiting, but merely as exemplifications ofpreferred embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appendedthereto.

What is claimed is:
 1. An electromechanical surgical system, comprising:an end effector configured to perform at least one function; a shaftassembly being arranged for selectively interconnecting the end effectorand a hand-held surgical instrument, the hand-held surgical instrumentincluding an instrument housing defining a connecting portion forselectively connecting with the shaft assembly; a motor assembly; asensor array configured to obtain at least one acoustic metric of thehand-held surgical instrument; and a controller configured to controloperation of the hand-held surgical instrument based on the acousticmetric obtained by the sensor array.
 2. The electromechanical surgicalsystem of claim 1, wherein the hand-held surgical instrument includes atransceiver configured to communicate with an external device.
 3. Theelectromechanical surgical system of claim 2, wherein the externaldevice is at least one of a charging device, a local sever, or anexternal server.
 4. The electromechanical surgical system of claim 3,wherein the hand-held surgical instrument communicates with the chargingdevice, the local server, or the external server via a cloud.
 5. Theelectromechanical surgical system of claim 1, wherein the sensor arrayincludes at least one acoustic sensor, temperature sensor, voltagesensor, current sensor, or vibration sensor.
 6. An electromechanicalsurgical system, comprising: an end effector configured to perform atleast one function; a shaft assembly being arranged for selectivelyinterconnecting the end effector and a hand-held surgical instrument,the hand-held surgical instrument including an instrument housingdefining a connecting portion for selectively connecting with the shaftassembly; a motor assembly; a sensor array configured to obtain at leastone electrical metric of the hand-held surgical instrument; and acontroller configured to control operation of the hand-held surgicalinstrument based on the electrical metric obtained by the sensor array.7. The electromechanical surgical system of claim 6, wherein thehand-held surgical instrument includes a transceiver configured tocommunicate with an external device.
 8. The electromechanical surgicalsystem of claim 7, wherein the external device is at least one of acharging device, a local sever, or an external server.
 9. Theelectromechanical surgical system of claim 8, wherein the hand-heldsurgical instrument communicates with the charging device, the localserver, or the external server via a cloud.
 10. The electromechanicalsurgical system of claim 6, wherein the sensor array includes at leastone acoustic sensor, temperature sensor, voltage sensor, current sensor,or vibration sensor.
 11. An end of life state determination method for ahand-held surgical instrument, the method comprising: obtaining at leastone acoustic or electrical metric of the hand-held surgical instrument;comparing the at least one acoustic or electrical metric to a thresholdvalue; and disabling the hand-held surgical instrument when the at leastone acoustic or electrical metric is greater than the threshold value.12. The method of claim 11, further comprising presetting the thresholdvalue by a manufacturer.
 13. The method of claim 11, further comprisingsetting the threshold value as a function of a measured characteristic.14. The method of claim 11, further comprising adjusting the thresholdvalue as a function of continually aggregated field data.
 15. The methodof claim 14, wherein the continually aggregated field data is at leastone of device performance, geographical metrics, hospital conditionmetrics, clinician metrics, regional based performance metrics,geographic based performance metrics, or time zone based performancemetrics.
 16. An end of life state prolonging method for a hand-heldsurgical instrument, the method comprising: obtaining at least oneoperational parameter of the hand-held surgical instrument; comparingthe at least one operational parameter to a predetermined thresholdvalue; determining that a device parameter of the hand-held surgicalinstrument can be augmented when the at least one operational parameteris greater than the predetermined threshold value; and augmenting thedevice parameter of the hand-held surgical instrument when the deviceparameter can be augmented.
 17. The method of claim 16, wherein when thedevice parameter of the hand-held surgical instrument cannot beaugmented, the hand-held surgical instrument is disabled.
 18. The methodof claim 16, wherein the threshold value is set by a manufacturer. 19.The method of claim 16, wherein the threshold value is set as a functionof a characteristic measured during manufacturing.
 20. The method ofclaim 16, wherein the threshold value is set as a function ofcontinually aggregated field data.
 21. The method of claim 20, whereinthe continually aggregated field data is at least one of deviceperformance, geographical metrics, hospital condition metrics, clinicianmetrics, regional based performance metrics, geographic basedperformance metrics, or time zone based performance metrics.